DLBCL

A look back at all the FDA news that happened in the month of September 2018, including several new approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.

Patients with CD30-expressing peripheral T-cell lymphoma who were treated with the combination of brentuximab vedotin and frontline chemotherapy experienced a statistically significant improvement in progression-free and overall survival, according to topline results from the phase III ECHELON-2 trial.

Philip Bierman, MD, discusses the current landscape of central nervous system involvement in aggressive lymphoma and the research that still needs to be conducted.

Antibody–drug conjugate therapies are making a larger impact on the treatment paradigm for patients with lymphomas, especially following promising data for brentuximab vedotin and inotuzumab ozogamicin.

During a presentation on diffuse large B-cell lymphoma at the 2018 SOHO Annual Meeting, Thomas E. Witzig, MD, discussed several ongoing trials that hope to raise the cure rate above the 80% threshold.

Pontchartrain Cancer Center was founded in 2005 to serve an area of Louisiana that lacked the necessary resources for cancer care. This community cancer center, with 2 locations in Southeast Louisiana, accommodates any patient to walk through its doors, filling a major unmet need for the community in this rural area.

The partial clinical hold previously placed on trials examining tazemetostat in patients with various solid tumors and hematologic malignancies has been lifted by the FDA and enrollment has been reopened.

Quick progress was seen with a novel class of agents, chimeric antigen receptor T-cell therapies, in the setting of diffuse large B-cell lymphoma—a swift jump from early phase clinical trials to FDA-approved products.

Despite decades of drug development and a deepening understanding of the biology of diffuse large B-cell lymphoma, physicians haven’t seen much improvement in cure rates, Thomas E. Witzig, MD, said during a presentation at the 2018 SOHO Annual Meeting.

Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, following at least 2 lines of systemic therapy. 

Tisagenlecleucel has gained approval from the European Commission as a treatment for adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.

Targeting EZH2, the catalytic subunit of the multiprotein PRC2, may represent an attractive therapeutic objective in malignant lymphoma, Vincent Ribrag, MD, told his audience at the American Association for Cancer Research’s inaugural Advances in Malignant Lymphoma meeting.

Julie M. Vose, MD, MBA, Chief in the Division of Oncology/Hematology at the University of Nebraska Medical Center, discusses strategies for overcoming resistance in lymphoma during the 2018 Pan Pacific Lymphoma Conference. 

Mogamulizumab-kpkc (Poteligeo) has been approved by the FDA as a treatment for patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

Now that chimeric antigen receptor T-cell therapies have received FDA approval for diffuse large B-cell lymphoma (DLBCL) after moving quickly through early phase clinical trials, research is now exploring ways to shift these agents earlier in the treatment paradigm, according to a discussion at the 2nd Annual Live Medical Crossfire on Hematologic Malignancies.

In patients with untreated advanced-stage classical Hodgkin lymphoma, PET can be safely used to guide treatment after 2 cycles of upfront de-escalated BEACOPP, according to the final analysis of the phase III LYSA study presented at the 2018 European Hematology Association Congress.

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy. The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE‑170 trial.

An objective response rate was achieved in 18 of 37 patients with relapsed/refractory non-Hodgkin lymphoma who received the combination of the BTK inhibitor ibrutinib with the PI3K inhibitor buparlisib, according to findings of a phase I/II trial reported at the 2018 ASCO Annual Meeting.

Durable complete remissions were seen in 46% of patients with high-risk diffuse large B-cell lymphoma treated with the CAR T-cell therapy lisocabtagene maraleucel at 6 months. These results come from the updated findings from the phase I, multicenter TRANSCEND trial that were presented at the 2018 ASCO Annual Meeting.

Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.